Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner

A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have procedures in place that describe the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered 'approved.' You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain 'approved.' You may never have to pay a visit to your supplier if you have a good supplier control program in place.

Why should you Attend: Supplier qualification and assessment is required according to both QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Organizations can, however, spend much less time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment. It will also provide cost efficient and equally compliant options for many of the most common practices in supplier management programs.

Areas Covered in the Session:

• QSR and ISO requirements for supplier selection
• QSR and ISO requirements for supplier assessment
• Recommended processes for new supplier qualification in a cost efficient manner
• Recommended processes for current supplier assessment in a cost efficient manner
• Supplier-related corrective action: Practices, Documentation, and Follow-up
• Implementation of a lean system for supplier qualification, assessment, and related corrective action

• Supply chain management
• Purchasing management
• Regulatory management
• QA management
• Executive Management